Z-2332-2021 Class II Terminated
FDA device recall Z-2332-2021 was initiated by Beckman Coulter Inc. on July 15, 2021 and is designated Class II. Reason for recall: There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. The recall status is terminated (terminated June 4, 2024). Affected quantity: 180 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- July 15, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 units
Product Description
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Reason for Recall
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe.
Code Information
Software Version 2.0 and 2.1